BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 3

    MDR report key: 21233336 · Received January 24, 2025

    Report

    Report Number
    1038671-2025-00404
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    July 14, 2022
    Report Date
    February 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001238
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2023-00633, 1038671-2025-00403 D10 CONCOMITANTS: 3994035 200-02-32 - THREE PEG PATELLA 32MM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-00633, 1038671-2025-00403. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FRACTURE, TIBIAL LOOSENING, AND FEMORAL LOOSENING. OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FRACTURE, TIBIAL LOOSENING, AND FEMORAL LOOSENING. OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    PER INFORMATION RECEIVED BY THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 6 YEARS AND 9 MONTHS AFTER FIRST REPLACE THE PATIENT HAD A REVISION ON (B)(6) 2022. PATIENT EXPERIENCED OSTEOLYSIS, PAIN AND FAILURE OF IMPLANT. SEVERE POLY WEAR ALONG THE MEDIAL AND LATERAL SURFACE WITH A BROKEN PORTION OF THE PS POST TIP AS WELL. GROSSLY LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH MINIMAL BONE LOSS. MASSIVE DISTAL FEMORAL MEDIAL AND LATERAL CONDYLE BONE LOSS - MEDIAL CONDYLE WAS SO DAMAGED THERE WAS A FRACTURE PRESENT THAT REQUIRED TWO SCREW FIXATION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISED TO ANOTHER COMPANY'S DEVICES. PATIENT SENT TO PACU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016916 LOGIC FEMORAL PS CEM RIGHT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001238

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R SEE H11